FDA Loosens Controls on Air Removal System Devices

The Food and Drug Administration is formally reclassifying intravascular administration set air removal systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 4. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Anesthesia Safety Products, LLC related to the AirPurge System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Air removal systems will not be exempt from premarket notification requirements.